Company ยท US
Mri Interventions, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2020. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HAW | Neurological Stereotaxic Instrument | 4 |
| HBG | Drills, Burrs, Trephines & Accessories (Manual) | 3 |
| ORR | Neurological Stereotaxic Instrument, Real-Time Intraoperative Mri | 2 |
| GWG | Endoscope, Neurological | 1 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 1 |
| HBL | Holder, Head, Neurosurgical (Skull Clamp) | 1 |
| HCA | Catheter, Ventricular | 1 |
| MOS | Coil, Magnetic Resonance, Specialty | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 13, 2020 | K200079 | ClearPoint System and Accessories Mri Interventions, Inc. | HAW |
| Nov 15, 2019 | K191701 | Arcus Head Fixation Frame Mri Interventions, Inc. | HBL |
| Jun 21, 2019 | K191400 | Voyager Trajectory Array Guide (V-TAG) Mri Interventions, Inc. | HAW |
| Nov 20, 2018 | K181731 | MR Compatible Aspiration Kit Mri Interventions, Inc. | GWG |
| Nov 2, 2018 | K181195 | ClearPoint System Mri Interventions, Inc. | ORR |
| Oct 20, 2017 | K171257 | ClearPoint System Mri Interventions, Inc. | ORR |
| Mar 26, 2016 | K160129 | MRII Cranial Drill and Accessories Mri Interventions, Inc. | HBG |
| Mar 17, 2016 | K160434 | ClearPoint System Mri Interventions, Inc. | HAW |
| Oct 21, 2015 | K142505 | ClearPoint System Mri Interventions, Inc. | HAW |
| Jul 8, 2015 | K151536 | SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm Mri Interventions, Inc. | HBG |
| Mar 20, 2014 | K132436 | VARIOGUIDE DRILL KIT Mri Interventions, Inc. | HBE |
| Aug 16, 2013 | K123605 | SMARTFLOW CATHETER Mri Interventions, Inc. | HCA |
| Mar 22, 2013 | K122456 | MRII CRAINIAL DRILL Mri Interventions, Inc. | HBG |
| Sep 8, 2011 | K111802 | SV BRAIN ARRAY, SIEMENS 3T Mri Interventions, Inc. | MOS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||